Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NNC0487-0111 · 18 trials · 8 indications
Measured as percentage of body weight.
Measured in days.
Measured in days.
Measured as events/hour.
WOMAC is a participant reported outcome (PRO) measures symptoms in the areas of pain, stiffness, and physical function in participants with osteoarthritis of the hip and/or knee. The measure consists of 24 items yielding 3 subscale scores and 1 total score. WOMAC raw scores are transformed to a standardised 0 to 100 score range. Higher scores indicate worse pain, stiffness, physical function, and overall osteoarthritis-related disability. Subscale score for pain ranges 0-100, where higher score indicates worse pain. Measured as score on a scale.
Measured as score on a scale. Western Ontario and McMaster Universities Arthritis Index (WOMAC) measures symptoms in the areas of pain, stiffness, and physical function. The measure consists of 24 items yielding 3 subscale scores and 1 total score. WOMAC raw scores are transformed to a standardised 0 to 100 score range. Higher scores indicate worse pain, stiffness, physical function, and overall osteoarthritis- related disability.
Number of events
Number of events
Measured in kilojoules per day (kJ/day)
Measured as hours\*nanomole per liter (nmol\*h/L)
Measured as milligram per minute per kilogram (mg/min/kg)
Measured as percentage change of energy.
Measured as percentage change of energy.
Measured as percentage change of energy.
Number of events
Measured as hours\*nanomole per liter (h\*nmol/L).
Measured as hours\*nanomoles per liter (h\*nmol/L)
Number of events
| Arm | Type | Description |
|---|---|---|
| NNC0487-0111 | EXPERIMENTAL | Participants will receive NNC0487-0111 and placebo matched to semaglutide subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
| Semaglutide | ACTIVE_COMPARATOR | Participants will receive semaglutide and placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matched to NNC0487-011 s.c. once weekly. |
| NNC0487-0111 dose level 1 | EXPERIMENTAL | Participants will be randomized to receive NNC0487-0111 dose level 1 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
| NNC0487-0111 dose level 2 | EXPERIMENTAL | Participants will be randomized to receive NNC0487-0111 dose level 2 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
| NNC0487-0111 dose level 3 | EXPERIMENTAL | Participants will be randomized to receive NNC0487-0111 dose level 3 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
| NNC0487-0111 dose level 4 | EXPERIMENTAL | Participants will be randomized to receive NNC0487-0111 dose level 4 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
| Low Energy Diet (LED) | OTHER | Participants will receive a low-energy dietary designed to achieve a reduction in body weight. |
| Severe hepatic impairment | EXPERIMENTAL | Participants will receive single dose of NNC0487-0111 subcutaneously. |
| Moderate hepatic impairment | EXPERIMENTAL | Participants will receive single dose of NNC0487-0111 subcutaneously. |
| Mild hepatic impairment | EXPERIMENTAL | Participants will receive single dose of NNC0487-0111 subcutaneously. |
| Normal hepatic impairment | EXPERIMENTAL | Participants will receive single dose of NNC0487-0111 subcutaneously. |
| NNC0487-0111 (dose 1) | EXPERIMENTAL | Participants will be randomized to receive a single dose of NNC0487-0111. |
| NNC0487-0111 (dose 2) | EXPERIMENTAL | Participants will be randomized to receive a single dose of NNC0487-0111. |
| NNC0487-0111 (dose 3) | EXPERIMENTAL | Participants will be randomized to receive a single dose of NNC0487-0111. |
| Mild Renal Impairment | EXPERIMENTAL | Participants with mild renal impairment (estimated glomerular filtration rate \[eGFR\] - 60 - 89 milliliter per min \[mL/min\]) will administer a single dose of NNC0487-0111 on Day 1. |
| Moderate Renal Impairment | EXPERIMENTAL | Participants with moderate renal impairment (eGFR - 30 - 59 mL/min) will administer a single dose of NNC0487-0111 on Day 1. |
| Severe Renal Impairment | EXPERIMENTAL | Participants with severe renal impairment (eGFR - less than 30 mL/min not requiring dialysis) will administer a single dose of NNC0487-0111 on Day 1. |
| End-Stage Renal Disease (ESRD) | EXPERIMENTAL | Participants with ESRD (requiring dialysis treatment) will administer a single dose of NNC0487-0111 on Day 1. |
| Normal Renal Function | EXPERIMENTAL | Participants with normal renal function (eGFR - greater than or equals 90) will administer a single dose of NNC0487-0111 on Day 1. |
| Phase A: NNC0487-0111 (formulation D) | EXPERIMENTAL | Participants will receive once daily dose of six different dose levels (1-6) of NNC0487-0111 (formulation D) at increasing doses (the dose will be escalated every 3 weeks). |
| Phase A: NNC0487-0111 (formulation C) | ACTIVE_COMPARATOR | Participants will receive once daily dose of six different dose levels (1-6) of NNC0487-0111 (formulation C) at increasing doses (the dose will be escalated every 3 weeks). |
| Phase B: NNC0487-0111 (formulation D) | EXPERIMENTAL | Participants will receive once daily dose of dose level 6 of NNC0487-0111 (formulation D). |
| Phase B: NNC0487-0111 (formulation C) | ACTIVE_COMPARATOR | Participants will receive once daily dose of dose level 6 of NNC0487-0111 (formulation C). |
| Name | Type | Description |
|---|---|---|
| NNC0487-0111 | DRUG | NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. |
| Semaglutide | DRUG | Semaglutide will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. |
| Placebo (matched to NNC0487-0111) | DRUG | Placebo matched to NNC0487-0111 will be administered subcutaneously using pre- filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. |
| Placebo (matched to semaglutide) | DRUG | Placebo matched to semaglutide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. |
| Placebo | DRUG | Placebo (matched to NNC0487-011) will be administered subcutaneously. |
| Placebo (matched to NNC0487-0111 ) | DRUG | Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. |
| Placebo (NNC0487-0111) | DRUG | Placebo matching NNC0487-0111 will be administered as a subcutaneous (s.c. under the skin) injection. |
| LED | BEHAVIORAL | A meal plan and meal replacements will be provided by the investigators. |
| NNC0487-0111 (formulation D) | DRUG | Participants will receive NNC0487-0111 (formulation D) tablet once daily. |
| NNC0487-0111 (formulation C) | DRUG | Participants will receive NNC0487-0111 (formulation C) tablet once daily. |
Key Inclusion Criteria: * Male or female (sex at birth). * Age 18 years or above at the time of signing informed consent. * Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening. * Haemoglobin A1c (HbA1c) 7-10 percentage (%) (53-86 millimole per mole \[mmol/mol\]) (both inclusive) as ...
NNC0487-0111 is an investigational small molecule being developed by Novo Nordisk for the treatment of overweight, obesity, type 2 diabetes, and diabetes mellitus. It is currently in Phase 3 clinical development and is being studied in various patient populations, including those with reduced kidney or liver function.
NNC0487-0111 is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker symbol NVO. The company is conducting clinical trials to evaluate the drug's safety, tolerability, and efficacy in metabolic conditions such as obesity and type 2 diabetes.
NNC0487-0111 is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied for the treatment of overweight, obesity, type 2 diabetes, and diabetes mellitus, with ongoing trials assessing its effects on various patient populations.
NNC0487-0111 is being evaluated in multiple clinical trials, including NCT06559527, a completed Phase 1 study in participants with reduced or normal kidney function; NCT06820476, a completed Phase 1 study in Chinese male participants; NCT07587710, a Phase 1 study in people with reduced or normal liver function; and NCT07757087, a Phase 1 study on energy use after weight loss in adults with obesity.
Yes, NNC0487-0111 is being studied in patients with kidney or liver problems. Clinical trial NCT06559527 examined blood levels and tolerability in participants with reduced kidney function and normal kidney function, while NCT07587710 is investigating the same in people with reduced liver function and normal liver function.